06 Nov
|
Teva Pharmaceuticals
|
Whitchurch-Stouffville
06 Nov
Teva Pharmaceuticals
Whitchurch-Stouffville
We Are Teva
We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.
We Are Teva
We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the prospect to better health worldwide, together.
Our Team, Your Impact
We are seeking an Operations Technical Writer to support our Manufacturing team in a GMP-regulated pharmaceutical production environment. In this role, you will be responsible for creating, revising, and maintaining controlled manufacturing documentation while supporting investigations related to deviations, non-conformances, and quality events. This position is ideal for someone who enjoys technical writing, problem-solving, and collaborating across multiple departments to drive compliance and operational excellence.
How You’ll Spend Your Day
Technical Documentation
- Author, revise, and maintain controlled GMP documentation, including:
- Standard Operating Procedures (SOPs)
- Work Instructions (WIs)
- Job Aids
- Equipment Manuals
- Cleaning Procedures
- Manufacturing Support Documents
- Forms and Templates
- Training Materials
- Ensure documents meet site quality standards, formatting requirements, and regulatory expectations.
- Translate complex technical processes into clear and user-friendly instructions for operational personnel.
Investigations & Quality Support
- Lead and support investigations involving manufacturing deviations, non-conformances, procedural events, equipment issues, and quality concerns.
- Gather and assess information from batch records, equipment logs, electronic systems, environmental data, and employee interviews.
- Perform Root Cause Analysis (RCA) using tools such as:
- 5 Whys
- Fishbone Diagrams
- FMEA
- Assess impact on product quality, compliance, patient safety, and operational performance.
- Author investigation reports and support timely closure of quality events and CAPAs.
Training & Continuous Improvement
- Develop and update training materials.
- Partner with subject matter experts to document best practices and manufacturing standards.
- Support document lifecycle management within electronic quality management systems.
- Promote consistency and standardization across manufacturing documentation.
Required
Your Skills and Experience
- College Diploma in Science or a related discipline.
- Minimum 1 year of experience in a GMP-regulated pharmaceutical, biotechnology, medical device, or manufacturing environment.
- Experience authoring and revising controlled documentation.
- Strong technical writing and editing skills.
- Knowledge of Good Manufacturing Practices (cGMP).
- Proficiency with Microsoft Office (Word, Excel, PowerPoint, and Visio).
Preferred
- Bachelor's Degree in Science, Engineering, or a related field.
- 4+ years of pharmaceutical manufacturing experience, preferably in oral solid dosage manufacturing.
- Experience using quality systems such as TrackWise, Veeva, MasterControl, or similar platforms.
- Experience conducting investigations and developing CAPAs.
Knowledge & Skills
- Technical Writing Excellence
- Root Cause Analysis & Investigations
- Critical Thinking & Problem Solving
- Attention to Detail
- Document Control & Quality Systems
- Knowledge of Health Canada, FDA, ICH, and PIC/S GMP requirements
- Understanding of oral solid dose manufacturing processes, including dispen
📌 Operations Technical Writer (Whitchurch-Stouffville)
🏢 Teva Pharmaceuticals
📍 Whitchurch-Stouffville